UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009624 |
|---|---|
| Receipt number | R000011291 |
| Scientific Title | Development of physical training program for patients with dementia |
| Date of disclosure of the study information | 2012/12/25 |
| Last modified on | 2014/06/25 09:53:06 |
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Basic information
Public title
Development of physical training program for patients with dementia
Acronym
Development of physical training program for patients with dementia
Scientific Title
Development of physical training program for patients with dementia
Scientific Title:Acronym
Development of physical training program for patients with dementia
Region
| Japan |
Condition
Condition
Dementia
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether a specific, standardized training regimen can improve muscle strength and physical functioning in people with dementia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Maximum knee extension strength
10 m-gait performance test
Time Up and Go Test
Functional Independence Measure
Key secondary outcomes
Mini-Mental State Examination
Dementia Behavior Disturbance Scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group: Resistance training was targeted at knee extension muscle groups at a submaximal intensity (65% of one-repetition maximum) for 10 months (3 sets of 8 repetitions, three times a week) supervised by a qualified instructor.
Interventions/Control_2
Control group: Typical activities were flexibility exercise, calisthenics,
low-intensity training.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Eligibility criteria included presence of dementia, absence of delirium, palsy, or knee pain and injury, and the desire to participate in the study.
Key exclusion criteria
Individuals were excluded if they could not push against the dynamometer with their leg with physical guidance.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Suzuki |
Organization
Kitasato University
Division name
School of Allied Health Sciences
Zip code
Address
1-15-1 Kitasato, Minami-ku, Sagamihara City, Kanagawa
TEL
042-778-8874
maksuzu@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Suzuki |
Organization
Kitasato University
Division name
School of Allied Health Sciences
Zip code
Address
1-15-1 Kitasato, Minami-ku, Sagamihara City, Kanagawa
TEL
042-778-8874
Homepage URL
maksuzu@gmail.com
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Research Grants in the Humanities from the Mitsubishi Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Setagaya Municipal Kitazawa En
Hatsutomi Hoken Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
世田谷区立きたざわ苑（東京都）
初富保健病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 12 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 25 | Day |
Date of closure to data entry
| 2014 | Year | 10 | Month | 25 | Day |
Date trial data considered complete
| 2014 | Year | 10 | Month | 25 | Day |
Date analysis concluded
| 2014 | Year | 12 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 25 | Day |
Last modified on
| 2014 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011291
